Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study

NCT00986349 | Completed Results

• 1 other identifier: 08-2
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to demonstrate the safety and efficacy of the Gastrointestinal (GI) EndoBarrier in the glycemic control of diabetes in subjects with Type 2 diabetes.

Conditions

Type 2 Diabetes

Keywords

Diabetes; Weight Loss; GI Dynamics; EndoBarrier

Outcome Measures

Primary Outcomes (2)

• Assessment of Glycemic Control (HbA1c) Over Time

  HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12

  Baseline to 12 Months with device implanted

• Change in Anti-diabetes Medications

  Medications were classified as "increased" if the dose of one or more oral agents was higher or an additional glucose-lowering agent was utilized at the time of treatment completion after EndoBarrier implantation in comparison with baseline. Medications were classified as "decreased" if the dose of one or more oral agents was lowered or one or more agents were discontinued at the time of treatment completion in comparison with baseline. For subjects in which the dose of one oral glucose-lowering agent was increased and another agent decreased, the change in medications was classified as "not assessable."

  Baseline to 52 weeks

Secondary Outcomes (1)

• Total Weight Change (kg) at Week 52 Compared to Baseline Weight

  Baseline to 52 weeks

Other Outcomes (1)

• Fasting Plasma Glucose Over Time for All Subjects

  Baseline to 12 months post Device Explant

Study Arms (1)

Diabetes

EXPERIMENTAL

Single Arm

Device: EndoBarrier Liner

Interventions

EndoBarrier Liner DEVICE

52 week treatment of EnoBarrier Liner

Also known as: EndoBarrier Gastrointestial Liner, GI Sleeve

Diabetes

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects Age \> 18 years and ≤ 55 years
• Male or Female
• Subjects with Type 2 Diabetes who have been treated for ≤10 years and are on oral diabetic medications
• Subjects with an HbA1C \> 7.5 and ≤ 10.0%
• Subjects with a BMI \> 26 - \< 50
• Subjects willing to comply with study requirements
• Subjects who have signed an informed consent form
• Women who are post-menopausal, surgically sterile or on oral contraceptives and agree to remain on oral contraceptives for at least twenty-four (24) weeks after being implanted or the duration of their trial participation and agree not to become pregnant during the trial.

You may not qualify if:

• Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
• Subjects requiring insulin
• Subjects with probable insulin production failure (fasting C Peptide serum \<1ng/mL)
• Subjects that have autoimmune disease as evidenced by a positive anti-GAD blood test
• Subjects with a weight loss of \> 4.5 Kg (10 lbs) within the 12 Weeks of screening
• Subjects requiring prescription anticoagulation therapy
• Subjects with or a history of iron deficiency and/or iron deficiency anemia
• Subjects with or a history of abnormalities of the GI tract
• Subjects with symptomatic gallstones or kidney stones at the time of screening
• Subjects with a known infection
• Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
• Subjects mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the Investigator, makes the Subject a poor candidate for device placement or clinical trial participation
• Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant
• Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
• Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated)

Sponsors & Collaborators

• Morphic Medical Inc.: lead

Study Sites (1)

Hospital Alemão Oswaldo Cruz

São Paulo, CEP 01323-903, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Weight Loss

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Affairs Manager
• Organization: GI Dynamics, Inc.

pkeating@gidynamics.com

781.357.3261

Study Officials

• Ricardo Cohen, MD

  Hospital Alemão Oswaldo Cruz

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2009
• First Posted: September 29, 2009
• Study Start: June 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2012
• Last Updated: February 17, 2017
• Results First Posted: January 2, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)